An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.

NCT01734317 | Completed Results

• 1 other identifier: MxT Ag 02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Wound Healing

  Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.

  14 days and 21 days

Secondary Outcomes (1)

• Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal

  After 0/14/21 days treatment

Study Arms (1)

Dressing

EXPERIMENTAL

Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.

Device: Mepilex Transfer Ag

Interventions

Mepilex Transfer Ag DEVICE

A soft silicone wound contact layer.

Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
• One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
• Male or female
• From 18 years and above
• Either in- or out-patient
• Thermal burn injury
• Signed Informed Consent/Assent Form

You may not qualify if:

• Electrical, chemical burn etiology
• If any full thickness areas are present, these should not be \> 5 %
• Burn greater than 36 hrs old
• Burns to face
• Use of chemical/enzymatic and biological debridement within 7 days of investigation start
• Presence of inflammation or infection in burn wounds
• Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
• Subjects with lung injury or Subject being on a ventilator
• Subjects with dermatologic skin disorders or necrotizing processes
• Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
• Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
• Subject not expected to follow the investigation procedures
• Subjects previously included in this investigation
• Subjects included in other ongoing clinical investigation at present or during the past 30 days

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Florida Gulf-to-bay Anesthesiology

Tampa, Florida, 33606, United States

Location

Long Island Plastic Surgical Group, P.C

Garden City, New York, 11530, United States

Location

Results Point of Contact

• Title: Joan Wilson
• Organization: Mölnlycke Health Care

joan.wilson@molnlycke.com

+1 706-650-1012

Study Officials

• Hans Schweiger, MD

  Florida Gulf-toBay Anesthesiology, Tampa Bay Circle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 27, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 3, 2020
• Results First Posted: March 5, 2014

Record last verified: 2013-02

Locations

US (2)